luspatercept
Reblozyl · ATC code B03XA06
Also known as: Luspatersept
- Key facts
- Active substance
- luspatercept
- ATC code
- B03XA06
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Reblozyl 25 mg powder for solution for injection / Reblozyl 75 mg powder for solution for injection
- Marketing authorisation holder
- Bristol Myers Squibb Pharma EEIG
- Information as of
- 2026-10-28
Key facts
Luspatercept (Reblozyl) is an erythroid maturation agent given by subcutaneous injection to treat anaemia in myelodysplastic syndromes and β-thalassaemia.
What it is used for
- Treatment of anaemia in myelodysplastic syndromes (MDS).
- Treatment of anaemia in transfusion-dependent and non-transfusion-dependent β-thalassaemia.
- For the exact wording of the authorised indications, see the full text.
Dosing
- Starting dose 1 mg/kg every 3 weeks by subcutaneous injection (upper arm, thigh or abdomen); haemoglobin is assessed before each dose.
- MDS: target Hb 10 g/dL to 12 g/dL; with insufficient response after at least 2 doses, increase to 1.33 mg/kg, then 1.75 mg/kg (maximum every 3 weeks); increases no more often than every 6 weeks.
- Transfusion-dependent β-thalassaemia: without response after at least 2 doses, increase to a maximum of 1.25 mg/kg every 3 weeks.
- Non-transfusion-dependent β-thalassaemia: without an Hb increase of ≥ 1 g/dL after 2 doses, increase by one dose level, maximum 1.25 mg/kg every 3 weeks.
- Dose delays or reductions for adverse reactions or high Hb; see the full text.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Pregnancy.
- Patients requiring treatment to control the growth of extramedullary haemopoiesis (EMH) masses.
Important warnings
- Thromboembolic events (e.g. deep vein thrombosis, portal vein thrombosis, pulmonary emboli, ischaemic stroke), in β-thalassaemia mainly in splenectomised patients with other risk factors; thromboprophylaxis should be considered.
- Blood pressure increase (on average up to 5 mmHg); start only if blood pressure is adequately controlled and monitor before each dose.
- Extramedullary haemopoiesis masses with serious complications in non-transfusion-dependent β-thalassaemia; discontinue if they occur.
- Pregnancy test before starting and a patient card for women of childbearing potential.
Side effects
- MDS (at least 15%): fatigue, diarrhoea, nausea, asthenia, dizziness, peripheral oedema and back pain; Grade ≥ 3 hypertension events in 12.5%.
- Transfusion-dependent β-thalassaemia (at least 15%): headache, bone pain and arthralgia; the most serious reactions were thromboembolic events.
- Many symptoms occurred mainly during the first 3 months.
Interactions
- No formal interaction studies; iron-chelating agents had no effect on luspatercept pharmacokinetics.
Pregnancy and breastfeeding
- Contraindicated during pregnancy; contraception during treatment and for at least 3 months after the last dose.
- A decision is needed to stop breast-feeding during therapy and for 3 months after, or to stop therapy.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- ReblozylBristol Myers Squibb Pharma EEIG · EMEA/H/C/004444
Source: European Medicines Agency (EMA), product information
Turkey
- ReblozylBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Reblozyl
- Liechtenstein
- Reblozyl
- Norway
- Reblozyl
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Reblozyl – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/reblozyl-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.